Wednesday, August 31, 2011

FDA Releases Strategic Plan

FDA’s strategic plan “Advancing Regulatory Science at FDA” identifies eight priority areas. FDA plans to implement the scientific programs within the agency and also collaborate with partners in industry, academia and government.

The FDA plans to:

• Modernize toxicology to enhance product safety
• Stimulate innovation in clinical evaluations and personalized medicine
• Support new approaches to improve product manufacturing and quality
• Harness diverse data through information sciences
• Implement a new prevention-focused food safety system
• Develop medical countermeasures to protect against threats to the U.S
• Strengthen social and behavioral science to make informed decisions on regulated products
• Evaluate innovative emerging technologies.

FDA will examine new ways to evaluate emerging technologies through active research and collaborating with external partners. The goal is to develop innovative medical products while concurrently developing novel assessment tools and methodologies.

One of the ways they hope to achieve their goal is to establish an “Innovation Initiative” within the Center for Devices and Radiological Health (CDRH) that will work to develop new devices and assessment tools. In developing assessment tools for novel therapies, FDA will explore the role of wireless and information technologies to use in new medical therapies and diagnostics.

FDA hopes that the “Innovation Initiative” will enable the development, assessment, and approval of important devices and encourage early conversations with developers to make sure their ideas are translated into technologies.

FDA receives a vast amount of information from a variety of sources including product submissions, voluntary adverse event repots, de-identified data from healthcare providers, and results from surveys and basic scientific research. FDA realizes that successful integration and analysis of this data available from disparate sources could provide knowledge and insight not possible from just one source.

FDA is in the early stages of constructing the IT infrastructure needed to deal with the integration of complex data but realizes that in addition, new analytic approaches and tools will also be needed. In the future, FDA plans to do sophisticated data mining activities to support the enormous number of simultaneous queries from a large set of indexed data sources.

To view the Strategic Plan, go to or go to